100NX EXPRESS Upgrade Kit with VELOCITY 10134V

GUDID 10705037068166

100NX EXPRESS Upgrade Kit with VELOCITY

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer

• Primary Device ID: 10705037068166
• NIH Device Record Key: 65c581a6-1900-4b9a-b31e-4615aca85abc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 100NX EXPRESS Upgrade Kit with VELOCITY
• Version Model Number: 10134V
• Catalog Number: 10134V
• Company DUNS: 947451626
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705037068166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092622

FDA Product Code

• MLR: Sterilizer, chemical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-27
• Device Publish Date: 2021-07-19

Devices Manufactured by ADVANCED STERILIZATION PRODUCTS SERVICES INC.

• 10705037068685 - Evotech: 2024-02-23 Channel Separator, PNTX
• 10705037069309 - Evotech: 2024-02-23 Channel Connector Tube, Brown
• 10705037045013 - Evotech: 2023-08-23 Channel Connector Tube, Yellow
• 10705037000562 - Evotech: 2023-08-16 Channel Connector Tube, White
• 10705037048717 - ASP AEROFLEX: 2023-08-16 Automatic Endoscope Reprocessor
• 10705037014132 - Sterrad: 2023-06-22 Sterrad NX Sterilizer
• 10705037014460 - Sterrad: 2023-06-22 Sterrad 100s Sterilizer
• 10705037014491 - Sterrad: 2023-06-22 Sterrad 100 NX Sterilizer